Actively Recruiting

Phase Not Applicable
Age: 2Years - 6Years
All Genders
NCT05673096

Paediatric Autism Communication Therapy (PACT) in Children With Autism Spectrum Disorder

Led by University of Southern Denmark · Updated on 2024-12-11

280

Participants Needed

6

Research Sites

198 weeks

Total Duration

On this page

Sponsors

U

University of Southern Denmark

Lead Sponsor

C

Copenhagen Trial Unit, Center for Clinical Intervention Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

Paediatric Autism Communication Therapy (PACT) is a naturalistic developmental behavioural interventions to reduce autism symptoms. The aim of this trial is to assess the beneficial and harmful effects of PACT in 2-6 year-old children with a recent diagnosis of autism spectrum disorder.

CONDITIONS

Official Title

Paediatric Autism Communication Therapy (PACT) in Children With Autism Spectrum Disorder

Who Can Participate

Age: 2Years - 6Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 2 through 6 years (both inclusive)
  • Diagnosis of autism spectrum disorder meeting ICD-10 codes DF84.0, DF84.1, DF84.5, DF84.8
  • Autism Diagnostic Observation Schedule, 2nd Edition Calibrated Severity Score (ADOS-2 CSS) of 4 or higher
  • ASD diagnosis verified by DSM-5 Autism Spectrum Disorder Checklist
  • ASD must be the primary developmental disorder confirmed at a clinical conference
  • Parents have sufficient Danish or English language skills to communicate with the therapist
  • Signed informed consent by parents or legal guardians
Not Eligible

You will not qualify if you...

  • Child has a sibling already included in the trial
  • Hearing or visual impairment in the child or parent
  • Parent not available for regular therapy sessions as evaluated at the consent meeting

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Child and Adolescent Mental Health Center, Aabenraa, Region of Southern Denmark

Aabenraa, Denmark, 6200

Actively Recruiting

2

Child and Adolescent Mental Health Center, Aalborg, North Denmark Region

Aalborg, Denmark, 9000

Actively Recruiting

3

Child and Adolescent Psychiatric Dept., Skejby, Aarhus University Hospital

Aarhus, Denmark, 8200

Actively Recruiting

4

Child and Adolescent Mental Health Center, Capital Region of Denmark

Hellerup, Denmark, 2900

Actively Recruiting

5

Child and Adolescent Mental Health Center, Odense, Region of Southern Denmark

Odense, Denmark, 5000

Actively Recruiting

6

Department of Child and Adolescent Psychiatry, Copenhagen University Hospital

Roskilde, Denmark, 4000

Actively Recruiting

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Research Team

N

Niels Bilenberg, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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